NCT06075823Recruiting
Edge-to-edge Mitral Valve Repair in ATTR-CM
Effectiveness and Safety of Edge-to-edge MItral vaLve Repair in Patients With Significant mitraL rEgurgitatioN aNd cardIac ATTR amyLoidosis
Source: ClinicalTrials.gov · Last updated 16 Oct 2026
Brief summary (registry, in English)
No previous study has evaluated the effectiveness of transcatheter edge-to-edge mitral valve repair (TEER) in patients with ATTR-associated cardiomyopathy (ATTR-CM) and significant mitral regurgitation, as this specific patient population was specifically excluded from previous large TEER trials. From a pathophysiological perspective, effective treatment of significant regurgitant volume and consecutive improvement of forward volume appears highly desirable in a condition with intrinsically low output. However, whether this translates into improved functional capacity, better quality of life, and better clinical outcomes compared to conservative heart failure management alone remains to be investigated.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 106 (estimated)
- First submitted
- 27 Sept 2023
- Start date
- 1 Jan 2024
- Primary completion date
- 12 Dec 2027
- Lead sponsor
- Medical University of Vienna
- Diseases
- Amyloidosis
- NCT number
- NCT06075823
What you commit to
- Study type: Interventional
- Planned participants: 106
- From 1 Jan 2024 to the primary completion date, 12 Dec 2027
- 10 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior mitral valve leaflet surgery or any currently implanted prosthetic mitral valve, or any prior transcatheter mitral valve procedure
- Currently participating in another investigational device study that has not reached its primary endpoint
Other illness
- Aortic valve disease requiring surgery or transcatheter intervention
- Hemodynamic instability requiring inotropic support or mechanical heart assistance
- Life expectancy \<12 months due to non-cardiac conditions
- Active endocarditis or active rheumatic heart disease or leaflets degenerated from rheumatic disease (i.e., noncompliant, perforated)
- Active infections requiring current antibiotic therapy
Other
- AL-associated cardiomyopathy
- Severe right ventricular dysfunction
- Leaflet anatomy which may preclude TEER, proper device positioning on the leaflets or sufficient reduction in mitral regurgitation by TEER
- Echocardiographic evidence of intracardiac mass, thrombus or vegetation
- Transesophageal echocardiography (TEE) is contraindicated or high risk
- Pregnant or planning pregnancy within next 12 months
Who the study is looking for
- Proven ATTR-CM
- Significant symptomatic MR (3+ or 4+ by independent echocardiographic core laboratory assessment)
- Subject has been adequately treated per applicable standards, including for coronary artery disease and heart failure (e.g., diuretics)
- New York Heart Association (NYHA) functional class II, III, or ambulatory IV
- Local heart team has determined that mitral valve surgery will not be offered as a treatment option, even if the subject is randomized to the control group
- Left ventricular ejection fraction ≥20%
- Anatomical feasibility for TEER as per discretion of the implanting investigator
- Age 18 years or older
- Subject or guardian agrees to all provisions of the protocol, including the possibility of randomization to the Control group and returning for all required post-procedure follow-up visits, and has provided written informed consent
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (10)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medical University of Graz, Division of Cardiology Coordinator of this site? Confirm its status | Graz | Austria | Recruiting |
| Ordensklinikum Linz Elisabethinen, Internal Medicine 2, Cardiology Coordinator of this site? Confirm its status | Linz | Austria | Recruiting |
| University Hospital St. Pölten, Department of Internal Medicine 3 Coordinator of this site? Confirm its status | Sankt Pölten | Austria | Recruiting |
| Medical University of Vienna Coordinator of this site? Confirm its status | Vienna | Austria | Recruiting |
| Clinic Favoriten, 5th Medical Department, Cardiology Coordinator of this site? Confirm its status | Vienna | Austria | Recruiting |
| Hannover Medical School, Department of Cardiology and Angiology Coordinator of this site? Confirm its status | Hanover | Germany | Not yet recruiting |
| University Hospital Heidelberg, Department of Cardiology, Angiology and Respiratory Medicine Coordinator of this site? Confirm its status | Heidelberg | Germany | Recruiting |
| LMU University Hospital, Department of Medicine I Coordinator of this site? Confirm its status | München | Germany | Recruiting |
| ASST Papa Giovanni XXIII, Cardiovascular Department Coordinator of this site? Confirm its status | Bergamo | Italy | Not yet recruiting |
| ASST Spedali Civili di Brescia, Cardiology Coordinator of this site? Confirm its status | Brescia | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.